Quality R&D Lead

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United States
Collegeville, USA
Posting date: 28 Mar 2025
64918

Quality R&D Lead - Contract - Collegeville PA

Proclinical is seeking a Quality Integration Specialist to support the assessment and integration of quality plans for external partners.

Primary Responsibilities:

This role focuses on developing third-party quality strategies and ensuring compliance with data integrity, GxP regulations, and national health authority requirements. You will play a key role in promoting a culture of quality and safety while providing GMP expertise and regulatory compliance advice.

Skills & Requirements:

  • Understanding of GMP and project management skills.
  • Experience in risk management and manufacturing processes.
  • Problem-solving abilities and excellent communication skills.

The Quality R&D Lead's responsibilities will be:

  • Assess the quality posture of external partners to identify risks and improvement needs.
  • Oversee operational quality activities, including deviations, change controls, CAPAs, and batch release for drug substances and products.
  • Manage project workstream activities and escalate compliance issues as needed.
  • Build relationships with cross-functional teams and stakeholders.
  • Manage quality plans for projects to ensure business continuity.
  • Encourage collaboration for cross-functional input on key decisions.
  • Identify and manage quality and compliance risks from projects.
  • Drive continuous improvement in processes, value creation, and cost savings.
  • Implement robust root cause analysis and problem-solving tools.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

close